The present invention is a continued application of: International Patent Application No. PCT/KR02/00126, entitled “Nucleic acid hybridization assay method and device using cleavage technique responsive to complementary double strand of nucleic acids or oligonucleotides”, which was filed on Jan. 27, 2002 and claims the priority of Korean Patent Application No. 10-2001-0003956 entitled “Nucleic acid hybridization assay method and device using cleavage technique responsive to complementary double strand or single strand of nucleic acids or oligonucleotides”, filed on Jan. 27, 2001; International Patent Application No. PCT/KR02/01035 entitled “Micro valve apparatus using micro bead and method for controlling the same”, which was filed on May 31, 2002 and claims the priority of Korean Patent Application No. 10-2001-0031284 entitled “Micro valve apparatus using micro bead and method for controlling the same”, filed on May 31, 2001; Korean Patent Application No. 10-2002-17558 entitled “Bio disc and bio drive apparatus and assay method using the same”, filed on Mar. 27, 2002; Korean Patent Application No. 10-2005-0038765 entitled “Digital bio disc and digital bio drive apparatus and assay method using the same”, filed on May 6, 2005; and Korean Patent Application No. 10-2005-0057513 entitled “DVD (Bio-DVD) drive apparatus and assay method using the same”, filed on Jun. 26, 2005. The disclosures of the above previous applications are incorporated herein by reference in their entirety.
In the invention of the previously filed application, the nucleic acid hybridization assay method and device using a cleavage technique responsive to a complementary double strand or single strand of—nucleic acids are applicable to diverse quantitative or qualitative assay devices. In addition, the micro valve is an essential element to control the flow of fluid in a lab-on-a-chip.
In the invention of the previously filed application, the nucleic acid assay device may comprise a detector including an optical device, an electrochemical device, or an impedance measurement device to detect confined signal elements of cleaved signal elements. The detected results can be digitized as computer executable software and provided through an established communications network, such as the Internet, to a patient or a doctor. In this manner, a remote diagnostic system ensuring convenience to both patient and doctor can be implemented based on the nucleic acid assay device. An impedance measurement for the detector may include interdigitated array electrodes with confined signal elements or cleavable signal elements, as disclosed in the previous application. In the invention of the previously filed application, a fluorescence detecting method for detecting a fluorescence label is disclosed.
In the invention of the previously filed application, a solid-state substrate (or a solid-state container) including a channel for flowing a fluid on a surface of a substrate, a chamber for storing a buffer solution, a fluid hole for connecting the channel, and an assay site where an array of bio materials are disposed; a valve for closing and opening the fluid hole; at least one preparation chamber for preparing a serum or DNA sample from blood; a PCR chamber for amplifying the DNA sample; and various enzymes are disclosed. In the invention of the previously filed application, an azimuthal direction valve searching operation is disclosed. The azimuthal direction valve searching operation is performed by slowing rotating a spindle motor with the slider being stopped or by repeating short rotating and stopping of the spindle motor.
In the invention of the previously filed application, a method of identifying a model or a version of a bio disc by using a barcode pattern of production ID (identification) is disclosed.
As a continued application from the previous applications, the present invention relates to a bio memory disc where a lab-on-a-chip process system used for various assay-diagnosis units, a nucleic acid hybridization assay unit, and a immuno-assay unit and/or semiconductor memories are disposed; a bio memory disc drive apparatus for driving and controlling the bio memory disc and an optical disc (a CD or a DVD); and an assay method using the same.
Most clinical diagnostic assay devices developed so far for the detection of small quantities of analytes in fluids are used in serial or parallel connection with multiple-sample preparation and automated reagent addition devices for the simultaneous analysis of numerous test samples with higher efficiency. Such automated reagent preparation devices and automated multiplex analyzers are often integrated into a single device. Clinical laboratory analyzers of this type can accurately perform hundreds of assays using small quantities of samples and reagents in one hour automatically or semi-automatically.
However, these analyzers are expensive and only centralized laboratories and hospitals can afford them. Such centralization necessitates sample transport to the laboratory or hospital and often precludes urgent or emergent analysis of time-critical samples.
Thus, to address these problems, there is an increasing need for clinical analyzers which are cheap and easy-to-handle for everyone, such as clinical analyzers suitable for use at the patient bedside of in the patient's home without dedicated detectors.
As ultra-high speed Internet and large-storage-capacity semiconductor memory are widely provided, a simple storage media such as a CD, a DVD, or other optical discs are not attractive in the market. In addition, media fusion of the optical disc and the semiconductor memory are highly demanded.
Therefore, a bio memory disc on which a lab-on-a-chip process system and/or a semiconductor memory are disposed and a bio memory disc drive apparatus for driving and controlling an optical disc (a CD and a DVD) and the bio memory disc are needed.
In the present invention, a disc on which only the lab-on-a-chip process system is disposed is called a bio disc; a disc on which only the semiconductor memory is called a memory disc; and the bio disc and the memory disc are collectively called a bio memory disc.
The bio memory disc can be used as a substitute for a conventional DVD RAM. The current DVD RAM has a maximum storage capacity of 9.4 GB. However, since a semiconductor memory having a storage capacity of 32 GB has already been commercially provided, a bio memory disc including the semiconductor memory can have a high storage capacity. In addition, a plurality of semiconductor memories are integrated in the bio memory disc so as to increase storage capacity, so that the bio memory disc can be used as a substitute for an existing hard disc of a computer.
The general optical disc such a standard compact disc is constructed by stacking a 12 cm polycarbonate substrate, a reflective metal layer, a protective lacquer coating layer, and the like. In addition, a continuous spiral groove is formed as a reference alignment guide for incident laser is formed on the polycarbonate substrate. The CD and CD-ROM formats are in accordance with the industrial standard ISO 9660.
As is widely known to one of ordinary skilled in the art, information written to general optical discs, such as audio CDs, game CDs, refractivity in their dye layer. In a common CD using a differential reflectivity detection method, indentations of pits are formed in the CD to a depth on the order of one-eighth to one-quarter of the wavelength of an incident laser beam.
Various technologies regarding CD-based assay devices have been disclosed: “Optical confocal compact scanning optical microscope based on compact disc technology” (Applied Optics, Vol. 30, No. 10, 1991), “Gradient-index objectives for CD applications” (Applied Optics, Vol. 26, Issue 7, 1987), and “Miniature scanning optical microscope based on compact disc technology” (Proc. Soc. Photo-opt. instrument Eng. page 1139-1169, 1989).
Patents regarding CD-based assay devices include U.S. Pat. No. 4,279,862 entitled “Centrifugal photometric analyzer” (published on Jul. 12, 1981) and U.S. Pat. No. 4,141,954 entitled “Reaction tube assembly for automatic analyzer” (published on Feb. 27, 1979).
GB 1075800 (published on Jul. 12, 1967), entitled “Disc for centrifuge”, discloses a device for flowing a sample fluid supplied via n inject hole of a disc over its surface by centrifugal force. EP 3335946 (published on Apr. 12, 1965), entitled “Separating disks for centrifuge”, discloses an apparatus for separating fluid samples injected via an inject hole of a disc by inducing flow of the samples through channels or chambers formed in the disc by centrifugal force.
U.S. Pat. No. 4,311,039 (published on Jan. 19, 1982), entitled “Disc centrifuge photo-sediment meter”, discloses a disc type chemical assay device using centrifugal force and optical detection.
However, these discs are not provided with mechanical or physical valves, so that the fluid flow cannot be controlled during a high-speed rotation for separation of serum or DNA from blood. Therefore, these discs are not suitable for automation of diagnosis and assay, so that these discs cannot be suitably used for a lab-on-a-chip process system. In addition, an MP3 player using the semiconductor memory cannot reproduce a CD and a DVD. On the other hand, a CD player or a DVD player cannot reproduce the semiconductor memory but the optical disc.
However, the bio memory disc drive apparatus according to the present invention can reproduce a semiconductor memory as well as an optical disc (a CD and a DVD).
The bio memory disc according to the present invention can be used as a substitute for a conventional DVD RAM. The current DVD RAM has a maximum storage capacity of 9.4 GB. However, since a semiconductor memory having a storage capacity of 32 GB has already been commercially provided, a bio memory disc including the semiconductor memory can have a storage capacity higher than that of the DVD RAM. Accordingly, the bio memory disc can be used as a substitute for an existing hard disc of a computer.